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The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.
The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. The software makes a recommendation about what medication changes are appropriate with potential alternates. Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer-Assisted Decision Support | Experimental | These providers will use the CADS program to treat their enrolled patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-Assisted Decision Support | Other | The CADS software makes a recommendation about what medication changes are appropriate with potential alternates. CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year. Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month. They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit. Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1c | Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care". | baseline, 12, 24, 36, and 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major events | The number of major ("severe") hypoglycemic events whether subjective (undocumented) or objective (SMBG or other confirmation, need for intervention, seizure, coma), and emergency room visits for DM-related causes. | ongoing |
| Other DM-related events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert A Vigersky, M.D. | Walter Reed National Military Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits. |
| ongoing |
| Glucose measures | Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions | baseline, 12, 24, 36, 48 months |
| Blood pressure | Clinically significant or statistically detectable changes in BP | baseline, 12, 24, 36, and 48 months |
| Lipids | Clinically significant or statistically detectable changes in lipid profile. | baseline, 12, 24, 36, and 48 months |
| Patient satisfaction with treatment | Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ. | basline and 48 months |
| Quality of life | Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8. | baseline and 48 months |
| Degree of Acceptance | The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire. | baseline and 48 months |
| Acceptance of uploading data | The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire. | baseline, 12, 24, 36, and 48 months |
| Demographic variables | The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender. | baseline and 48 months |